The Wessex Fit-4-Cancer Surgery Trial
WesFit
A Pragmatic Factorial Design Randomised Controlled Study to Assess the Efficacy of the Implementation of a Prehabilitation Programme in Patients Undergoing Elective Major Intra - Cavity Cancer Surgery in Wessex
1 other identifier
interventional
1,560
1 country
1
Brief Summary
Trial Phase: Phase III: A multi-centre efficacy pragmatic factorial design randomised controlled trial with patient informed development and process evaluation Indication: Patients undergoing major electively resectable intra - cavity cancer surgery with or without neoadjuvant cancer treatments (including chemotherapy (NAC), chemoradiotherapy (CRT), or immunotherapy). Objective: To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support on surgical outcome by reducing postoperative length of stay (LOS) and complications. Secondary Objective: To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support to improve disease-free overall survival. Cardiopulmonary Exercise test (CPET) variables, physical activity, morbidity, radiological markers of sarcopenia, toxicity, tumour down-staging, tumour regression, disability adjusted survival (WHODAS) overall survival and quality of life (QoL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Mar 2018
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2018
CompletedStudy Start
First participant enrolled
March 26, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMay 9, 2019
May 1, 2019
2.9 years
March 7, 2018
May 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative length of hospital stay
Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS).
up to 1 year
Secondary Outcomes (43)
Change in objectively measured cardiopulmonary exercise testing variables - Oxygen uptake at anaerobic threshold (ml/kg/min) and oxygen uptake at peak exercise (ml/kg/min)
up to 15 weeks
Overall survival - 1
1 year post-operatively
Overall survival -2
5 years post-operatively
Disease free survival
1 year post-operatively
Post-operative morbidity -1
POMS at day 3,5,7 and 15.
- +38 more secondary outcomes
Study Arms (4)
Control
NO INTERVENTIONUsual care plus additional monitoring
SRETP
EXPERIMENTALStructured Responsive Exercise Training Programme (SRETP) prior to surgery
Psychological support
EXPERIMENTALPsychological support prior to surgery
SRETP and psychological support
EXPERIMENTALStructured Responsive Exercise Training Programme (SRETP) and psychological support prior to surgery
Interventions
SRETP will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. Exercise intensities during the interval exercise-training program are specific to each patient and derived from CPET. Moderate intensity exercise is below the anaerobic threshold (AT). Patients will exercise at 80% of oxygen uptake (VO2) obtained at the anaerobic threshold (80%AT) for moderate intensity exercise - 3 minutes. Severe exercise intensity is recognised as 50% of the difference between the VO2 AT and VO2 Peak (50%∆) - 2 minutes.
Support sessions will be patient-centred, giving the patient an opportunity to raise any issues/concerns they are having, this may include (but will not be limited to) ways of coping with their reactions to cancer, family and relationship issues, exploring personal issues and dealing with practical issues. Patients will have access to other resources available at the cancer centres including but not restricted to further information about their condition and how to access financial support. These processes reflect the best practice currently being delivered by cancer support centre staff in the Wessex region. Any patient deemed at risk (i.e. from suicidal ideation or self harm) will be reported to their GP, followed up by a letter.
Eligibility Criteria
You may qualify if:
- Male or female patients
- aged over 18 years old
- scheduled to have major intra-cavity cancer surgery with a curative intent, defined as thoracic, colorectal, oesophagogastric, urological and hepatobiliary (inc. pancreatic).
- surgery alone (unimodal)
- surgery combined (multimodal) with cancer treatments (neoadjuvant chemotherapy, chemoradiotherapy or immunotherapies).
- All patients deemed by the MDT as potentially curable or undergoing neoadjuvant cancer treatments prior to restaging and surgery.
You may not qualify if:
- Patients will be excluded if under the age of 18 years,
- if their tumour is considered surgically non- resectable,
- having absolute or relative contraindications to completing a CPET,
- patients are unable to perform CPET due to other coexisting acute illness or conditions (e.g. lower limb dysfunction),
- patients decline surgery,
- if their weight exceeds 145kg
- patients unable to give informed consent.
- Patients having \>2 mm ST depression if symptomatic or 4 mm if asymptomatic or \>1 mm ST elevation during any CPET will need to be withdrawn from study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Southampton NHS Foundation Trustlead
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trustcollaborator
- Portsmouth Hospitals NHS Trustcollaborator
- Hampshire Hospitals NHS Foundation Trustcollaborator
- Poole Hospital NHS Foundation Trustcollaborator
- Isle of Wight NHS Trustcollaborator
- Dorset County Hospital NHS Foundation Trustcollaborator
Study Sites (1)
University Hopsitals Southampton
Southampton, United Kingdom
Related Publications (1)
West M, Bates A, Grimmett C, Allen C, Green R, Hawkins L, Moyses H, Leggett S, Z H Levett D, Rickard S, Varkonyi-Sepp J, Williams F, Wootton S, Hayes M, P W Grocott M, Jack S. The Wessex Fit-4-Cancer Surgery Trial (WesFit): a protocol for a factorial-design, pragmatic randomised-controlled trial investigating the effects of a multi-modal prehabilitation programme in patients undergoing elective major intra-cavity cancer surgery. F1000Res. 2021 Sep 21;10:952. doi: 10.12688/f1000research.55324.2. eCollection 2021.
PMID: 36247802DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Samantha Leggett
University Hospitals Southampton NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masking of CPET assessors and dual reporting, masking of personnel involved in outcome data collection, masking of sarcopenia assessors
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
April 26, 2018
Study Start
March 26, 2018
Primary Completion
March 1, 2021
Study Completion
March 1, 2022
Last Updated
May 9, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share